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New treatment option for Stroke, Acute
Official title Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
ClinicalTrials.gov ID: NCT06107010
What this study is testing
- What it's testing
- The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial. This clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>18 years old
- First clinically significant disability due to stroke
- Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
- Functional Ambulation Category score (FAC) \<2
- Patient with health insurance
You likely can't join if
- Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician...
- Recent fracture (\< 3 months) or any therapy inducing secondary osteoporosis
- Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP -...
- Medical contra-indication to medium intensity physical strain
- Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
See the full eligibility criteria
- \>18 years old
- First clinically significant disability due to stroke
- Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke
- Functional Ambulation Category score (FAC) \<2
- Patient with health insurance
- Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he/she can still be included if the signature can...
- Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion
- Recent fracture (\< 3 months) or any therapy inducing secondary osteoporosis
- Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion
- Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA
- Medical contra-indication to medium intensity physical strain
- Orthostatic hypotension (loss of \> 20 mmHg systolic BP after 3 minutes in standing position)
- Uncontrolled seizures
- Morphological contra-indications to the use of Atalante (as per user's manual)
- Pregnant woman
- Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention
- Concurrent participation in another treatment trial
The study team makes the final eligibility decision.
Where it's taking place
- Créteil, France
- Pionsat, France
- Bad Aibling, Germany
- Berlin, Germany
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Créteil, France; Pionsat, France; Bad Aibling, Germany; Berlin, Germany; Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.